Effects of Carbon Dioxide Infrared Laser Moxibustion on Pain and Function in Knee Osteoarthritis (CILM-KOA)

February 18, 2026 updated by: Rehana Yasmeen Niazi, University of Lahore

Effects of Carbon Dioxide Infrared Laser Moxibustion in Patients With Knee Osteoarthritis: A Double-Blind Randomized Controlled Trial

Knee osteoarthritis is a prevalent degenerative joint disorder characterized by chronic knee pain, stiffness, reduced range of motion, and limitations in daily functional activities. Exercise therapy is widely recommended as a first-line conservative approach to reduce symptoms and improve physical performance; however, a substantial proportion of patients continue to experience persistent pain and functional impairment despite adherence to exercise-based rehabilitation.

Carbon dioxide (CO2) infrared laser moxibustion is a non-invasive far-infrared thermal stimulation modality intended to reproduce the localized heating effects of traditional moxibustion without smoke or odor. It is hypothesized to enhance local microcirculation, support tissue oxygenation, and modulate inflammatory activity, thereby contributing to symptom relief and improved joint function. This double-blind, parallel-group randomized controlled trial will evaluate whether adding carbon dioxide (CO2) infrared laser moxibustion to a standardized knee osteoarthritis exercise program provides greater improvement than exercise alone. Eligible participants with radiographic knee osteoarthritis will be randomly allocated to either (1) an exercise-only program or (2) the same exercise program plus carbon dioxide (CO2) infrared laser moxibustion delivered over an 8-week treatment phase (24 sessions). Outcomes will be measured at baseline and at follow-up visits at Month 3 and Month 6 to determine changes in pain intensity measured by the Numerical Pain Rating Scale (NPRS), knee range of motion measured by goniometry, articular cartilage thickness measured by magnetic resonance imaging (MRI), and biochemical markers including bone alkaline phosphatase (BAP) and serum calcium.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a double-blind, parallel-group randomized controlled trial examining the effectiveness of carbon dioxide (CO2) infrared laser moxibustion as an adjunct to exercise therapy in individuals with knee osteoarthritis. Knee osteoarthritis is a multifactorial degenerative condition involving mechanical stress, low-grade inflammation, and progressive joint tissue changes that contribute to pain, restricted movement, and functional limitations. Exercise therapy represents a core component of conservative management; however, residual symptoms are frequently reported, supporting the evaluation of additional non-pharmacological approaches.

Carbon dioxide (CO2) infrared laser moxibustion is a non-invasive modality that delivers far-infrared thermal stimulation to predefined knee-related treatment points, intended to reproduce the therapeutic effects of traditional moxibustion without smoke exposure. Proposed mechanisms include enhancement of local microcirculation, modulation of inflammatory activity, neuromodulatory analgesic effects, and potential support of local tissue metabolism. Participants with radiographic knee osteoarthritis will be allocated to either a standardized exercise program alone or the same exercise program combined with carbon dioxide (CO2) infrared laser moxibustion delivered during an 8-week treatment period.

Participants will be assessed at baseline, at the end of the 8-week intervention period, and during follow-up visits at Month 3 and Month 6 to evaluate short-term and medium-term changes in pain and knee-related outcomes. The findings of this study will contribute to the evidence base for rehabilitation strategies in knee osteoarthritis and inform the potential role of carbon dioxide (CO2) infrared laser moxibustion as an adjunct conservative intervention.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Lahore, Pakistan, 54000
        • Rashid Latif Medical College, Lahore, Pakistan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

Adults aged 55 to 65 years, male or female. Diagnosis of knee osteoarthritis with radiographic evidence (Kellgren-Lawrence grade 2 or higher).

Knee osteoarthritis grade II or III according to the American Rheumatism Association (ARA) classification criteria.

History of moderate to severe knee pain on most days during the past month. Able and willing to provide written informed consent and comply with study procedures.

Exclusion Criteria

Other diseases affecting the knee, such as rheumatoid arthritis, ankylosing spondylitis, fibromyalgia syndrome, or chronic fatigue syndrome.

Use of steroid medication or acupuncture or moxibustion treatment within the previous 3 months.

Intra-articular hyaluronate injection within the previous 6 months. Arthrocentesis or arthroscopy within the previous 1 year. Knee or hip replacement surgery, or planned joint replacement surgery during the trial period.

Use of other external treatments during the trial (e.g., topical medication for knee pain).

Body mass index (BMI) greater than 30 kg/m². Lower-limb fracture or injury affecting function. Neurological disorders or nerve root compression affecting the lower limb.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exercise Program Only (Control)
Participants receive a standardized knee osteoarthritis exercise program delivered over an 8-week intervention period, with three supervised sessions per week (24 sessions total). Each session lasts approximately 40 minutes and includes warm-up activities followed by progressive strengthening and mobility exercises targeting the knee and surrounding musculature, including step-ups, chair sit-to-stand exercises, quadriceps strengthening, isometric thigh activation, and balance or coordination exercises. Clinical outcomes are measured at baseline, at the end of the 8-week intervention period, and at follow-up visits at Month 3 and Month 6 according to the study protocol.
Other: Exercise Program for Knee Osteoarthritis
Participants receive a standardized knee osteoarthritis exercise program delivered over an 8-week intervention period, with three supervised sessions per week (24 sessions total), with each session lasting approximately 40 minutes. The program includes warm-up activities followed by progressive strengthening and mobility exercises targeting the knee and surrounding musculature, including step-ups, chair sit-to-stand exercises, quadriceps strengthening, isometric thigh activation, and balance or coordination exercises.
Device: CO2 Infrared Laser Moxibustion (CILM)
CO₂ infrared laser moxibustion is administered using a 10.6 μm CO₂ infrared laser device with an output power range of 160-180 mW. The defocused probe is positioned approximately 2 cm from the skin, producing a light spot with a diameter of approximately 2 cm. Irradiation is applied to predefined knee-related points (ST35, Ex-LE4, and Ashi points) bilaterally, with each point treated for approximately 5 minutes per knee. The total irradiation time per session is approximately 30 minutes, including bilateral point application, with additional time allocated for positioning and safety checks, resulting in a total session duration of approximately 40 minutes. Treatment is delivered three sessions per week for eight weeks (24 sessions total) according to a standardized protocol.
Other Names:
  • 10.6 μm Infrared Laser Moxibustion
  • 10.6 μm CO₂ Laser Moxibustion
Experimental: Exercise Program Plus Carbon Dioxide (CO2) Infrared Laser Moxibustion (CILM)
Participants receive the same standardized knee osteoarthritis exercise program delivered over an 8-week intervention period, with three supervised sessions per week (24 sessions total; approximately 40 minutes per session), in combination with carbon dioxide (CO2) infrared laser moxibustion. Carbon dioxide (CO2) infrared laser moxibustion is administered using a 10.6 micrometer CO2 infrared laser device with an output power range of 160 to 180 mW. The defocused probe is positioned approximately 2 cm from the skin, producing a light spot with a diameter of approximately 2 cm. Irradiation is applied to predefined knee-related treatment points including ST35 (Dubi), Ex-LE4 (Neixiyan), and Ashi (tender points), applied bilaterally, with each point treated for approximately 5 minutes per knee. The total irradiation time per session is approximately 30 minutes, with additional time allocated for positioning and safety checks, resulting in a total session duration of approximately 40 minute
Other: Exercise Program for Knee Osteoarthritis
Participants receive a standardized knee osteoarthritis exercise program delivered over an 8-week intervention period, with three supervised sessions per week (24 sessions total), with each session lasting approximately 40 minutes. The program includes warm-up activities followed by progressive strengthening and mobility exercises targeting the knee and surrounding musculature, including step-ups, chair sit-to-stand exercises, quadriceps strengthening, isometric thigh activation, and balance or coordination exercises.
Device: CO2 Infrared Laser Moxibustion (CILM)
CO₂ infrared laser moxibustion is administered using a 10.6 μm CO₂ infrared laser device with an output power range of 160-180 mW. The defocused probe is positioned approximately 2 cm from the skin, producing a light spot with a diameter of approximately 2 cm. Irradiation is applied to predefined knee-related points (ST35, Ex-LE4, and Ashi points) bilaterally, with each point treated for approximately 5 minutes per knee. The total irradiation time per session is approximately 30 minutes, including bilateral point application, with additional time allocated for positioning and safety checks, resulting in a total session duration of approximately 40 minutes. Treatment is delivered three sessions per week for eight weeks (24 sessions total) according to a standardized protocol.
Other Names:
  • 10.6 μm Infrared Laser Moxibustion
  • 10.6 μm CO₂ Laser Moxibustion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity measured by the Numerical Pain Rating Scale (0 to 10)
Time Frame: Baseline and Week 8
Change in knee pain intensity measured using the 0 to 10 Numerical Pain Rating Scale (0 = no pain, 10 = worst possible pain).
Baseline and Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee range of motion in flexion and extension
Time Frame: Baseline, Week 8, Month 3, and Month 6
Change in knee joint range of motion in degrees measured using a goniometer.
Baseline, Week 8, Month 3, and Month 6
Articular cartilage thickness measured by magnetic resonance imaging (MRI)
Time Frame: Baseline and Month 6
Change in knee articular cartilage thickness measured using magnetic resonance imaging.
Baseline and Month 6
Serum bone alkaline phosphatase (BAP)
Time Frame: Baseline, Month 3, and Month 6
Change in serum bone alkaline phosphatase concentration measured from venous blood samples.
Baseline, Month 3, and Month 6
Serum calcium concentration
Time Frame: Baseline, Month 3, and Month 6
Change in serum calcium concentration measured from venous blood samples.
Baseline, Month 3, and Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lahore

Investigators

  • Study Director: Ashfaq Ahmed, University Institute of Physical Therapy Univesity of Lahore Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2025

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 18, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UOL-IREB-25-12-0037-70137698

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared because the study involves identifiable clinical and imaging data collected at local hospital sites, and there is currently no institutional infrastructure or approved data-sharing agreement for external distribution. De-identified data may be made available upon reasonable request to the corresponding investigator, subject to ethics approval and institutional policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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